Current testing methods can leave critical performance gaps undiscovered until clinical trials

 

Performance Testing Under Challenging Physiological Conditions

Conventional test methods struggle to reveal how devices perform in low saturation, low PI, and other hard-to-reproduce conditions. 

Inability to Reproduce Identical Test Conditions

Variability between human test subjects can obscure performance issues, slowing development and increasing downstream risk.

Unexpected Rework from Late-Discovered Performance Gaps

When performance gaps are discovered late, teams face redesign, schedule delays, or narrower claims.

The later performance issues are discovered, the harder and more expensive they are to correct.

How PPG simulation fills the Pre-Clinical Test Gap

 

Validate Full Performance Range Before Human Studies

Validate device behavior across claimed performance ranges under controlled, repeatable lab conditions before human evaluations.

Enable Repeatable Testing Without Relying on Human Subjects

Replay identical heart rate, SpO2, and PI values while eliminating human subject variability, enabling consistent result comparisons.

Defensible Performance Data Helps Prevent Late-Stage Surprises

When performance gaps are identified early under controlled conditions, teams can address them before they disrupt human studies or force costly redesign.
Talk to An Expert

Trusted by Leading Medical Device Teams Worldwide

 

“Before implementing AECG100, it was difficult to systematically validate our SpO₂ performance range under controlled conditions.
Simulation allowed us to verify edge cases and calibration behavior before entering human evaluation, significantly reducing downstream risk.”

— Eric Hsiao Ph.D., Wearable Biosensing Researcher, Former Biosensor Engineer at Analog Devices


Learn More About the Solution

 

AECG100

ECG, PPG and PWTT Multifunction Tester

PPG-2R-880

Reflectance SpO2 Module

PPG-2R-880

Solution Overview

PPG Testing Solution at a Glance
Download the 1-page solution overview for key takeaways

 

Real-World Insight

Learn from an Independent Expert
How a Former ADI Biosensor Engineer Evaluates Reflective PPG Validation Methods

Reference Testing Workflow from Renesas Electronics Corporation
See a Renesas-published example of reflective SpO₂ test setup and procedure using PPG simulation
 

 

Technical Fundamentals

From Simulation to Clinical Trials
Building a risk-reduced V&V workflow for wearable PPG devices

How to Test SpO₂ at 70%
Validating low-saturation performance under controlled conditions

 

Practical Testing Guidance

Application Note — AECG100 (ECG, PPG and PWTT Multifunction Tester)
How to Test Wearable Devices with Reflectance-Based Pulse Oximeter Function

 

Validate Before Clinical Trials
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